Document a4BvVVwkrd387OpgD2ag6BR4B

REPORT OF A GOOD LABORATORY PRACTICE INSPECTION COMPLIANCE REVIEW AND STUDY AUDITS CONDUCTED PURSUANT TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) LABORATORY: ScitoVation 100 Capitola Dr. Suite 106 Durham, NC 27713 INSPECTION NUMBER: 2020295019 RESPONSIBLE OFFICIAL: Dr. Marjory Moreau Phone: 919-354-5220 Mmoreau@scitovation.com DATE OF INSPECTION: SIGNATURES: Inspector/Auditor: February 6, 2020 WILLIAM WIMBISH Digitally signed by WILLIAM WIMBISH Date: 2020.02.26 10:25:11 -05'00' William Wimbish, Compliance Officer Office of Compliance/GLP Administrative/ Technical Reviewer: MARK LEHR Digitally signed by MARK LEHR Date: 2020.02.26 06:24:40 -07'00' Approver: Digitally signed by FRANCISCA FRANCISCA LIEM LIEM Date: 2020.02.28 10:22:15 -05'00' SUMMARY Page 2 of 4 A U.S. Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, Rodenticide, Act (FIFRA) Good Laboratory Practice (GLP) inspection was conducted to determine compliance with 40 CFR 160 and 40 CFR 169.2(k). One study audit was conducted by the inspector. In addition, a GLP compliance inspection was conducted to determine the laboratories current adherence to the GLP regulations. Findings from the FIFRA GLP inspection and study audits are summarized below. There was no documentation that the program was validated 40 CFR 169. (2)(k) I. INTRODUCTION A Neutral Scheme FIFRA GLP inspection was conducted at ScitoVation, on February 6, 2020 to determine compliance with 40 CFR 160 and 40 CFR 169.2(k). The inspector assigned was Mr. William Wimbish and was accompanied by Ms. Frances Liem, Director of U.S. EPA's GLP Program. ScitoVation has two main scientific branches in their company focusing on Computational Toxicology and Cell-Based Assays. ScitoVation does not currently perform GLP work. For more information visit: https://www.scitovation.com/ II. OPENING CONFERENCE An opening conference was held beginning at approximately 9:00am on February 6, 2020. The inspection was led by Mr. William Wimbish, Physical Scientist, from the EPA's GLP Program. Official credentials were presented to Dr. Moreau, Manager. A FIFRA Notice of Inspection [Exhibit 1] was also presented to and signed by Dr. Moreau. A list of attendees at the opening and closing conference is provided as [Exhibit 4]. III. NARRATIVE The following GLP compliance inspection and study audits were accomplished during the inspection. GLP Compliance Inspection: The GLP standards compliance inspection was conducted through interviews with facility personnel and tours of laboratory. Personnel curricula vitae and training records were reviewed. No ongoing study was audited. Study Audit: Page 3 of 4 One study audit was accomplished through review of available raw data, records, reports, interviews with study personnel and a review of laboratory operations. The audit was based on: completeness of raw data, conformance of raw data to study report findings and conclusions, and record keeping. The following describe observations made and activities undertaken during the facility inspection and audit of the study with respect to the U.S. EPA FIFRA GLP regulations under 40 CFR 160: Study Title: 50879601 / Development and Application of Physiologically-Based Pharmacokinetic Models to the Evaluation of Age-Dependent Sensitivity to Pyrethroid Insecticides Sponsor: Council for the Advancement of Pyrethroid Human Risk Assessment, LLC (CAPHRA) c/o Household and Commercial Products Association 1667 K Street NW, Suite 300 Washington, DC 20006 Finding: There was no documentation that the program was validated Citation: 40 CFR 169. (2)(k) Facility Response: Facility Response [Exhibit 5] IV. EXIT DISCUSSION The exit conference was held Thursday February 6, 2020 by William Wimbish to review findings and recommendations of the FIFRA GLP standards inspection and data audit. Inspection Observations form [Exhibit 2] was completed and copied for the facility providing written indication of the inspector's observations discussed during the inspection and closing conference. A FIFRA Receipt for Samples [Exhibit 3] was provided to the facility for documents obtained during the inspection. V. EXHIBITS Exhibit 1 Exhibit 2 Exhibit 3 Exhibit 4 Exhibit 5 FIFRA Notice of Inspection Inspection Observations form FIFRA Receipt for Samples Sign-in Sheet Facility Response Page 4 of 4 (1 page) (1 page) (1 page) (2 pages) (4 pages) Exhibit 1 Exhibit 2 Exhibit 3 Exhibit 4